Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care

• Status: Terminated
• Trial end date: 2019-03-27
• Target enrollment: 0
• Participant gender: All

Summary

In this proposal, the investigators will determine if a single dose of oral lorazepam reduces distress, pain severity, and need for opiate analgesics both in the ED and in the acute recovery period after discharge. The investigators will compare the lorazepam arm to a placebo arm.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Pacella
• Collaborators: The UPMC Mercy Emergency Medicine Fund; University of Pittsburgh Physicians
• Treatments: Lorazepam

Criteria

Inclusion Criteria:

• Adults between the ages of 18-65

• Sustained a physical injury with a pain score ≥ 5 on the numeric rating scale [NRS] from 0- 10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable"

• Expected to be in the ED for at least 2 hours, in a private treatment room

• Ownership of a cell phone with text messaging capabilities

• Emergency Department admission assessment confirmed subject is not suicidal.

Exclusion Criteria:

• Non-English speaking

• Not medically suitable for lorazepam per treating MD (e.g. medical condition where benzodiazepines are contraindicated or may be unsafe)

• Not alert and oriented

• Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team

• Seeking treatment due to a mental health or substance use disorder

• History of chronic opioid use

• Prescribed opioid or benzodiazepine use within the past 24 hours

• Alcohol use within the past 12 hours or medical history of alcoholism.

• Clinical indication for open-label benzodiazepine administration in the ED.

• Any use of recreational narcotics throughout lifetime

• Sensitivity or allergy or intolerance to opioids or benzodiazepines

• Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)

• Prisoner